| CTRI Number |
CTRI/2020/06/025696 [Registered on: 08/06/2020] Trial Registered Prospectively |
| Last Modified On: |
05/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical trial of NRL/2019/NMP in promoting health and well-being in healthy adults |
|
Scientific Title of Study
|
Clinical validation of NRL/2019/NMP with micronutrient fortification to assess the efficacy and safety in promoting health and well-being in healthy adults-Randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| MHC/CT/19-20/016 Ver 1.0 dated 15th Feb 2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr NILESH CHANDRAWANSHI |
| Designation |
Counsultant |
| Affiliation |
Sai Hospital |
| Address |
Sai hospital near hanuman temple akurdi pune
Pune
MAHARASHTRA
411035
India |
| Phone |
8149256707 |
| Fax |
|
| Email |
ncwanshi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Omkar Kulkarni |
| Designation |
Senior Manager, Research & Development |
| Affiliation |
Netsurf Research Labs Pvt Ltd |
| Address |
Netsurf Communications Pvt. Ltd.
107 Plot 2 Laxman Nagar Baner Road Baner PUNE 411045
Pune
MAHARASHTRA
411045
India |
| Phone |
09922435119 |
| Fax |
|
| Email |
omkar.kulkarni@nrl.net.in |
|
Details of Contact Person
Public Query
|
| Name |
Omkar Kulkarni |
| Designation |
Senior Manager, Research & Development |
| Affiliation |
Netsurf Research Labs Pvt Ltd |
| Address |
Netsurf Communications Pvt. Ltd.
107 Plot 2 Laxman Nagar Baner Road Baner PUNE 411045
Pune
MAHARASHTRA
411045
India |
| Phone |
09922435119 |
| Fax |
|
| Email |
omkar.kulkarni@nrl.net.in |
|
|
Source of Monetary or Material Support
|
| Netsurf Communications Pvt.Ltd. |
|
|
Primary Sponsor
|
| Name |
Netsurf Communications Pvt Ltd |
| Address |
107 Plot 2 Laxman Nagar Baner Road Baner PUNE 411045 (Maharashtra) India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nilesh Chandrawanshi |
Sai Hospital |
Near hanuman temple akurdi pune
Pune
MAHARASHTRA |
8149256707
ncwanshi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Royal Pune Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Health and well being |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NRL/2019/NMP |
10 gm protein supplement with 150 ml milk |
| Comparator Agent |
Marketed product |
10 gm Protein supplement with 150 ml milk |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18 years to 65 years
BMI in the range of 20 to 26
Subjects in good physical condition and sound mental status
In the judgment of the Principal Investigator able to comply with protocol requirements Subjects willing to sign written informed consent
Willingness to abstain from use of vitamin or mineral supplements, nutritional supplements and or medical foods if applicable |
|
| ExclusionCriteria |
| Details |
Allergies to ingredients in product/ milk
Subjects with uncontrolled and uncomplicated diabetes (HbA1C NMT 7.0 percentage and blood pressure NMT 140/90 mm hg) may or may not be on prescription.
Subjects with past history of addiction abuse and rehabilitation
Subject more than 2 events of alcohol consumption per week
Subjects with current medical history of any major illness such as cancer, heart disease, COPD ,Asthma etc. in the past
Subjects with history of any acute or chronic illness that may affect the patient’s participation in the study
Use of prescription medications and/or nonprescription medications for weight loss.
Subjects with acute illness or history of major or minor surgery in the past one year
Female subjects who are currently pregnant and/or breast feeding
Subjects not willing to participate in study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Daily energy questionnaire Endurance levels by VO2 max Perceived stress levels
Immunity via number of events of recurrent UTI/RTI etc.
Anthropometric analysis
HbA1c and glycemic profile ie blood sugar levels
Regulation of lipid levels |
Baseline, day 30, 60 and 90. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of life (Physical, mental and social) General Health Questionnaire-28 (GHQ-28)
Changes in digestive behavior assessment
Changes in mood behavior
Safety profiling by LFT, RFT and thyroid profile etc. Assessment of Overall Improvement by subject and investigator
Adverse events
Changes in sleep quality questionnaire
Palatability with dosage compliance of test product |
Baseline, day 30, 60 and 90. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
11/06/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not publishing |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
By taking in to consideration the need of good protein supplement
for both male and female, the netsurf communication has designed and developed
the NRL/2019/NMP protein supplement with micronutrient fortification for both
male and female to help to manage health and quality of life. The current research is undertaken to assess the efficacy and
safety of the NRL/2019/NMP with micronutrient fortification to promote health
and wellbeing in healthy adults.
|